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MedTech Outlook | Friday, August 30, 2019
The breakthrough designations will enable the company to assist more patients with its robust drug delivery medical devices.
FREMONT, CA: Concept Medical recently received Breakthrough Device Designation by the FDA for MagicTouch with three different indications. Earlier in April, the company had received Breakthrough Device Designation for its MagicTouch Sirolimus Coated Balloon Catheter, indicated for percutaneous transluminal coronary angioplasty.
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Recently in August, it was given the designation for MagicTouch PTA Sirolimus Coated Balloon Catheter, indicated for percutaneous transluminal angioplasty and the designation for MagicTouch AVF Sirolimus Coated Balloon Catheter for percutaneous transluminal angioplasty for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae or graft.
The MagicTouch PTA Sirolimus drug-coated balloon is designed for the treatment of peripheral artery disease below the knee. A clinical trial assessing the safety and efficacy of the device for the treatment of below the knee and femoropopliteal lesions is in progress.
Dr. Manish Doshi, President and CEO at Concept Medical, said, “It took years of research to master the Limus drug delivery platform technology to devise an innovative product like MagicTouch. It has been commercially used with over 25,000 patients worldwide, with highest usage in patients in the European region. Besides commercial sales, MagicTouch has been evaluated extensively in clinical studies conducted in countries like UK, Italy, and Brazil. MagicTouch is also commercially available for patients in India. We are now excited to begin our work with the US FDA in bringing our technology to serve the patients in the USA.”
Headquartered in Tampa, Florida, Concept Medical is a pioneer in the drug delivery medical devices industry. The company has offices in Singapore, the Netherlands, Brazil, and commercial sales in Europe, Asia, and the Middle East, among others. Concept Medical has a robust pipeline of products and clinical programs carried out in several countries.
The late mortality signals discovered by researchers and FDA specialists had led to the convention of an advisory panel, which recommended the agency to update device labels to warn the patients. It had led to a lag in the treatment of below the knee PAD using paclitaxel-coated devices.
Dr. Kiran Patel, Chairman at Concept Medical, said, “The FDA’s designation of MagicTouch for the Breakthrough Device Program will allow CMI to meet its ambition to provide this promising technology and innovative treatment for ISR patients in the USA. Our confidence in MagicTouch emanates from the positive feedback that we are receiving from the users of our product from current and ongoing commercial sales of MagicTouch in many European countries. CMI is encouraged that the selection of MagicTouch, with its unique drug delivery technology, for the FDA's Breakthrough Device Program may allow timely access of this promising new technology to the US patients with coronary ISR with a potential to provide safe and effective treatment”.
The breakthrough device designation will empower the company to interact more closely with the FDA reviewers employed to assess the device. The agency is likely to accept a greater extent of the uncertainty of the benefit risk-profile for devices if they present probable benefits to patients with earlier access to the devices. However, premarket approval has to be bolstered with adequate postmarket controls.
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